- Reference: 44810
- Job Type: Permanent
- Location: Offaly, Westmeath
- Category: Medical Devices
New position – Midlands – seeking an Experienced Quality Assurance MANAGER – Medical Devices.
Role Title: QA Manager, located in Tullamore.
This role will be responsible for the management of QA team (inclusive of 2 Supervisors and approx. 11 QA staff members), be the Management Quality representative inside and outside the facility (Competent Authorities / Notified Bodies, etc) and be an active and effective part of the Management team of the Site.
Reporting to the Senior Director of QA & Compliance for Europe the role requires a minimum qualification of a Degree in a science based discipline, preferably Master’s Degree in a scientific or engineering discipline or equivalent with 15 years’ experience or more in the medical device or pharmaceutical industry, with strong analytical skills, exceptional writing and interpersonal relationship skills.
Package for the successful candidate will be competitive market rate:
Assures quality products and processes, and Quality Standard Compliance by establishing, enforcing and maintaining quality MAP and compliant QMS. Establishes and maintains a permanent improvement process of the QA Organization and of the Quality System. Ensures the full compliance of QA activities with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements. Management of QA staff, and be the Management Quality representative inside and outside the plant (Competent Authorities / Notified Bodies, etc).
- Ensure that all aspects of the operational business in the site comply with cGMP legal and regulatory requirements as well as Group Quality Manual and Policies.
- Provides direction, management support and leadership for QA/FDA remediation plans to insure compliance with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements.
- Ensure that compliance and quality risks are understood and are always integral part of business decisions.
- Establish and follow QA training program for the whole site.
- Support and supervise QA upgrade projects, harmonisation and ensure compliance with current standards.
- Implement a supplier QA program for the suppliers and sub-contractors associated with the Ireland products, including performing & co-ordination of supplier audits.
- Manage, support and supervise quality projects and ensure that quality problems and technical matters are resolved consistent with global standards.
- Liaises with Operations, PD, and others departments to prospectively plan QA support for project milestones.
- Organize and conduct external Inspections (FDA , Corporate) and follow their remediation plan.
- Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
- Proactive, analytical and predictive mind-set to
- Ensure timely and complete site reporting, including relevant KPI and indicators.
- Drive continuous improvement and efficiency initiatives in Quality operations.
- Carry out other tasks or responsibilities as directed, to continuously improve Quality Assurance within the Company.
- Manage QA budgets.
- Revision of existing product documentation as required.
- Create Technical Bulletins, Label designs and Product User guides as required.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:
- Minimum BSc, preferably Master’s Degree in a scientific or engineering discipline or equivalent with 15 years’ experience or more in the medical device or pharmaceutical industry, strong analytical skills, exceptional writing and interpersonal relationship skills.
- Demonstrated knowledge of EU regulations, FDA regulations, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
- Demonstrate ability to increase value delivered by team through Performance management and successful challenging of underperformance.
- Strong project Management skills with a proven track record of successful execution of major programs
- Strong Leadership skills with a tested and proven desire to motivate individuals, and hold team members accountable for performance.
- Experience in Process Excellence tools is highly desirable.
This process will move quickly.
For a confidential discussion and more information on the role, please contact Mary Mullin on 09064 78104 and email your cv and cover note to email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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